Version 1
: Received: 6 January 2023 / Approved: 10 January 2023 / Online: 10 January 2023 (07:13:00 CET)
Version 2
: Received: 25 February 2023 / Approved: 28 February 2023 / Online: 28 February 2023 (01:50:35 CET)
Sørbye, S.W.; Falang, B.M.; Antonsen, M. Performance of a 7-Type HPV mRNA Test in Triage of HPV DNA Primary Screen Positive Women Compared to Liquid-Based Cytology. J. Mol. Pathol.2023, 4, 69-80.
Sørbye, S.W.; Falang, B.M.; Antonsen, M. Performance of a 7-Type HPV mRNA Test in Triage of HPV DNA Primary Screen Positive Women Compared to Liquid-Based Cytology. J. Mol. Pathol. 2023, 4, 69-80.
Sørbye, S.W.; Falang, B.M.; Antonsen, M. Performance of a 7-Type HPV mRNA Test in Triage of HPV DNA Primary Screen Positive Women Compared to Liquid-Based Cytology. J. Mol. Pathol.2023, 4, 69-80.
Sørbye, S.W.; Falang, B.M.; Antonsen, M. Performance of a 7-Type HPV mRNA Test in Triage of HPV DNA Primary Screen Positive Women Compared to Liquid-Based Cytology. J. Mol. Pathol. 2023, 4, 69-80.
Abstract
Background: A plethora of data supports HPV-based screening to be the preferred strategy for cervical cancer prevention. The shift to a more sensitive firstline test brings the need of effective triage up for discussion. Currently, most algorithms apply cytology as triage of HPV-DNA positive women. This study compared the performance of a 7-type HPV-mRNA test to cytology.Methods: From 2019-01-01, until 2021-12-31, cervical samples from 58,029 women were examined at the University Hospital of North Norway. 30.5% (17,684/58,029) fulfilled the criteria for HPV-DNA primary screening. All positive samples were triaged by cytology and followed-up according to national guidelines through 2022. Additionally, a 7-type HPV-mRNA test was applied. Study endpoint was histologically confirmed high grade lesion (CIN2+).Results: 5.6% (990/17,684) had positive HPV-DNA test, 97.2% (962/990) with valid HPV-mRNA results. 55.5% (534/962) had abnormal cytology (ASC-US+) and 35.1% (338/962) had positive HPV-mRNA test. 13.9% (134/962) had CIN2+. Sensitivity (CIN2+) of cytology versus the HPV-mRNA test was 76.1% (102/134)) versus 73.1% (98/134)), p=0.67. The specificity was 47.8% (396/828) versus 71.0% (588/624), p<0.001. PPV was 19.1% (102/534) and 29.0% (98/338), p<0.001 respectively. The number of colposcopies per CIN2+ detected by cytology and HPV-mRNA test was 5.2 and 3.1.Conclusion: The 7-type HPV mRNA test was significant more specific than cervical cytology in triage of HPV-DNA positive women. Using this biomarker as threshold for colposcopy may better balance the benefits and harms of screening.
Medicine and Pharmacology, Pathology and Pathobiology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Received:
28 February 2023
Commenter:
Sveinung Sorbye
Commenter's Conflict of Interests:
Author
Comment: All women participating in HPV primary screening in North Norway (Troms and Finnmark county) over the period 2019-01-01 throughout 2021-12-31(17,684) have been followed up according to the Norwegian guidelines, resulting in a CIN2+ prevalence among study population at 9.8% (94/962).The study is ongoing, and we have revised the manuscript to include the results for women followed up throughout December 2022, increasing the number of CIN2+ cases from (n=94) to (n=134)being eligible for re-analysis, hereby allowing for a more accurate comparison between the two triage methods.
Commenter: Sveinung Sorbye
Commenter's Conflict of Interests: Author